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General| Sample Type | Whole blood |
|---|---|
| Measured Parameters | Clotting time |
| Type | Coagulation Analyzer |
| Power Supply | AC adapter or battery |
| Measurement Principle | Mechanical detection of clot formation |
| Accuracy | ±5% or ±2 seconds (whichever is greater) |
Explains text conventions used throughout the manual.
Describes the serial number label on the instrument and its components.
Lists and explains symbols found on product labeling and their meanings.
Displays icons for main navigation and functions on the home screen.
Shows icons indicating the battery charge level and status.
Illustrates icons for network connection status and types.
Explains icons related to test status, operations, and sample handling.
Specifies the intended use of the GEM Hemochron 100 system and its tests.
Outlines the required training and proficiency for using the instrument.
Identifies and describes the physical components of the GEM Hemochron 100 instrument.
Lists materials provided with the instrument and those required but not provided.
Describes the rechargeable lithium-ion battery and factors affecting its life.
Provides instructions on how to charge the instrument's battery using the provided power supply.
Explains how to interact with touchscreen elements by tapping.
Describes how to navigate through lists or content that exceeds screen capacity.
Details how to use the on-screen virtual keyboard for text input.
Differentiates between Instrument Operator and Supervisor roles and their access levels.
Covers basic user configurable settings like screen rotation, timer, brightness, and volume.
Provides instructions for connecting the instrument via an Ethernet cable.
Sets requirements for OID entry (None, Scan/Manual, Scan Only).
Sets requirements for PID entry (None, Scan/Manual, Scan Only).
Covers safety, QC lockout, cartridge use, and sample preparation for patient tests.
Provides guidelines for collecting quality blood samples for coagulation testing.
Details the internal EQC testing process for instrument validation.
Explains how to perform LQC tests using external controls and cartridges.
Introduces the instrument database for storing and managing test results.
Provides instructions for routine cleaning and maintenance of the instrument.
Outlines the process for obtaining instrument repair services.
Addresses issues related to connecting the instrument to a network or CCM.
Provides instructions for safely removing, replacing, and disposing of the battery.
Details the proper disposal of biohazardous materials like samples and cartridges.
Introduces the CCM software for centralized configuration and management of instruments.
Describes the different account types (Admin, Supervisor, Operator) for CCM and the instrument.
Details the installation process and firewall configuration for CCM.
Details miscellaneous settings affecting CCM operation like display language and log file limits.
Covers network settings for CCM, including pinging instruments and port configurations.
Explains how to add instruments to CCM and create instrument groups.
Explains how to enter cartridge lot numbers and expiration dates into CCM.
Explains how to view and export the audit log file for CCM activity.
Details wireless specifications and compliance with FCC and ISED regulations.
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